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Nirogacestat in Ovarian Granulosa Cell Tumors

Sponsor
SpringWorks Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05348356
Collaborator
(none)
43
Enrollment
21
Locations
1
Arm
64
Anticipated Duration (Months)
2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase 2 clinical trial will study the effectiveness of nirogacestat in ovarian granulosa cell tumors (OvGCTs). Nirogacestat is a gamma secretase inhibitor (GSI) which is hypothesized to decrease the growth and activity of ovarian granulosa tumors.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Ovarian granulosa cell tumors (OvGCTs) represent 5-7% of all ovarian cancers (~1.5 to 2k newly diagnosed patients/year in the United States) and are the most common subtype of ovarian sex cord tumors (70%). Treatment of granulosa cell tumors with nirogacestat is expected to inhibit Notch-induced granulosa cell proliferation.

This is a multi-center, single-arm, Phase 2 open label treatment study to determine the efficacy, safety, tolerability, and pharmacokinetics of nirogacestat in adult participants with relapsed/refractory OvGCT. The participants will continue treatment until disease progression as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or unacceptable toxicity.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
43 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Granulosa Cell Tumors
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nirogacestat Open-Label

All participants will receive open-label nirogacestat

Drug: Nirogacestat
nirogacestat oral tablet
Other Names:
  • PF-03084014

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) [2.5 years]

      The proportion of participants with complete response (CR) + partial response (PR) assessed using RECIST v1.1 criteria.

    Secondary Outcome Measures

    1. Progression Free Survival at 6 months (PFS-6) [First day of cycle 7 (approximately 6 months after the first dose of study treatment). Each cycle is 28 days.]

      The number of participants without progression according to RECIST v1.1 or death at 6 months.

    2. Overall Survival [2 years after first dose of study treatment]

      The number of participants who have not died of any cause.

    3. Participant reported ovarian cancer symptoms [At each study visit until study completion (estimated to be an average of 2.5 years)]

      Change from baseline as measured by Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI).

    4. Duration of Response [First day of every other cycle (each cycle is 28 days) for the first year, and then every 3 cycles thereafter until study completion (estimated to be an average of 2.5 years).]

      The time from response (CR + PR using RECIST v.1.) to disease progression and/or death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Has histologically confirmed recurrent adult-type granulosa cell tumor of the ovary prior to first dose of study treatment

    • Have documented radiological evidence of relapse after at least one systemic therapy that is not amenable to surgery, or radiation and have measurable disease by RECIST v1.1 criteria

    • Have adequate bone marrow, renal and hepatic function as defined by screening visit laboratory values

    Key Exclusion Criteria:

    • Has signs of bowel obstruction requiring parental nutrition, malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat

    • Has had a major cardio or thrombo-embolic event within 6 months of signing informed consent

    • Has abnormal QT interval at Screening, or has congenital or acquired long QT syndrome or a history of additional risk factors for Torsades de Pointes

    • Has current or chronic history of liver disease or known hepatic or biliary abnormalities

    • Has received any treatment for OvGCT including but not limited to the following within 28 days (or 5 half-lives, whichever is longer) prior to the first dose of study treatment: anti-angiogenic therapy, hormonal therapy, chemotherapy, immunotherapy, targeted therapy or any investigational treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SpringWorks Clinical Site Los Angeles California United States 90024
    2 SpringWorks Clinical Site Los Angeles California United States 90033
    3 SpringWorks Clinical Site Palo Alto California United States 94304
    4 SpringWorks Clinical Site Orlando Florida United States 32806
    5 SpringWorks Clinical Site Tampa Florida United States 33612
    6 SpringWorks Clinical Trial Covington Louisiana United States 70433
    7 SpringWorks Clinical Site Baltimore Maryland United States 21204
    8 SpringWorks Clinical Site Boston Massachusetts United States 02215
    9 SpringWorks Clinical Site Buffalo New York United States 14203
    10 SpringWorks Clinical Site New York New York United States 10065
    11 Kettering Health Kettering Ohio United States 45429
    12 SpringWorks Clinical Site Houston Texas United States 77030
    13 SpringWorks Clinical Site Seattle Washington United States 98195
    14 SpringWorks Clinical Site Milwaukee Wisconsin United States 53226
    15 SpringWorks Clinical Site Winnipeg Manitoba Canada R3E 0V9
    16 SpringWorks Clinical Site Montréal Quebec Canada H2W 1T8
    17 SpringWorks Clinical Site Sherbrooke Quebec Canada J1H 5N4
    18 SpringWorks Clinical Site Białystok Poland 15-027
    19 SpringWorks Clnical Site Kraków Poland 30-376
    20 SpringWorks Clinical Site Poznań Poland 60-569
    21 SpringWorks clinical Site Warsaw Poland 02-034

    Sponsors and Collaborators

    • SpringWorks Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SpringWorks Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT05348356
    Other Study ID Numbers:
    • NIR-OGT-201
    First Posted:
    Apr 27, 2022
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Granulosa Cell Tumor

    Study Results

    No Results Posted as of Jul 15, 2022